BridgeMD
New treatment option for Spinal Cord Injuries
Official title Novel Soluble Epoxide Hydrolase Inhibitor for Neuropathic Pain in Patients With Spinal Cord Injury
ClinicalTrials.gov ID: NCT06438471
What this study is testing
What is EC5026 oral tablet?
EC5026 oral tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for spinal cord injuries.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate safety and tolerability of multiple oral doses of EC5026 in male and female patients with neuropathic pain due to traumatic or non-traumatic (degenerative) spinal cord injury. The main question it aims to answer is whether EC5026 is safe and well tolerated in SCI patients with neuropathic pain.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Each subject must meet all of the following criteria to be enrolled in this study:
- Male and female people must be 18 and older.
- people must be willing to provide written informed consent to participate in the study.
- people must be able to provide own transportation to study site every day for the duration of the study.
- people with either a traumatic or a non-traumatic SCI may be eligible to enroll in this study. For people with complete or incomplete traumatic...
You likely can't join if
- For people with degenerative partial spinal cord injuries (pSCI): people must have an incomplete, non-traumatic, SCI at any level secondary to...
- people must have completed a minimum of 6 of the 7 daily assessments for average and worst daily pain prior to final screening, using an 11-point...
- people must have failed at least 2 classes of medications for their neuropathic pain due to SCI (classes may include antidepressants, antiepileptics...
- people must be in overall stable condition, as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12 lead...
- people must have normal or not clinically significant clinical laboratory test results, as determined by the study investigator, including...
- people must have a negative screening for HIV, Hepatitis C, and Hepatitis B within 30 days of randomization.
See the full eligibility criteria
Who can join
- Each subject must meet all of the following criteria to be enrolled in this study:
- Male and female people must be 18 and older.
- people must be willing to provide written informed consent to participate in the study.
- people must be able to provide own transportation to study site every day for the duration of the study.
- people with either a traumatic or a non-traumatic SCI may be eligible to enroll in this study. For people with complete or incomplete traumatic spinal cord injuries (tSCI), or complete non-traumatic spinal cord injury...
What rules you out
- For people with degenerative partial spinal cord injuries (pSCI): people must have an incomplete, non-traumatic, SCI at any level secondary to degenerative spinal disorders such as disc degeneration, spinal stenosis, or...
- people must have completed a minimum of 6 of the 7 daily assessments for average and worst daily pain prior to final screening, using an 11-point numerical rating scale (NRS) for average daily pain intensity, and the...
- people must have failed at least 2 classes of medications for their neuropathic pain due to SCI (classes may include antidepressants, antiepileptics, opioids, anti-inflammatories, topical treatments, etc.).
- people must be in overall stable condition, as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12 lead ECG measurements
- people must have normal or not clinically significant clinical laboratory test results, as determined by the study investigator, including coagulation panel, blood cell counts, comprehensive metabolic panel analytes...
- people must have a negative screening for HIV, Hepatitis C, and Hepatitis B within 30 days of randomization.
- people must have a normal hypothalamic-pituitary-adrenal and hypothalamic-pituitary-gonadal axes screening study.
- people must have a negative urinary drug screen (UDS) for illicit drugs (marihuana/THC are allowed) and serum ethanol level \<80 mg/dL.
- Male people who are not surgically sterile (vasectomized) and their female sexual partners must agree to use contraception during the study period and for 2 months afterward.
- Male people must not donate sperm during the study and for 12 months after receiving the last dose of study drug.
- Female people must be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, or surgically sterile (bilateral tubal ligation ('clipping or tying tubes' or hysterectomy) for at least 3 months, or...
- people must be able to speak, read, and understand English sufficiently to allow comprehension and completion of all study assessments. Exclusion Criteria: people meeting any of the following criteria will be excluded...
- Ventilator-dependent people, with the exception of nocturnal use of CPAP or BiPAP.
- people with pain that is not present every day (chronic) or where the pain description does not have a classic neuropathic phenotype.
- people with other chronic neuropathic pain conditions, including painful diabetic neuropathy, HIV-associated neuropathic pain, chemotherapy or ethanol-associated neuropathy.
- people with other pain syndromes that may confound assessment or self-evaluation of the SCI neuropathic pain.
- people with only negative symptoms, defined as numbness without clear evidence of spontaneous pain, either constant or episodic.
- Non-opioid pain medications will be allowed if at a fixed stable dose for more than 1 month prior to Screening with no anticipation of the dose changing during the study, and if they do not interfere with the subject's...
- people using opioid medications will be required to be on a dose of 60 morphine milligrams equivalents (MME) per day or less, and with a stable dose for at least four (4) weeks prior to consent, with no anticipation of...
- people with active Hepatitis A, Hepatitis B and/or Hepatitis C.
- people with any clinically unstable or significant cardiovascular (including acute coronary syndrome within the prior year to Screening), renal, hepatic, respiratory, gastrointestinal, hematological, endocrine, or...
- people with clinically significant abnormalities on screening vital signs, laboratory tests, and/or ECG. people with poor venous access will also be excluded.
- people with a history of disorders of the hypothalamic-pituitary-adrenal axis, including adrenal insufficiency and Cushing's, or with a history of disorders of the hypothalamic-pituitary-gonadal axis, including...
- people who have used any topical, oral, or intravenous exogenous corticosteroids within 12 weeks and/or intra-articular exogenous corticosteroids within 6 months prior to the start of the trial, or who plan on using...
- people who have used fludrocortisone or exogenous testosterone products within 12 weeks prior to the start of the trial or who plan on using them during the study.
- people who have used (within 14 of randomization) or plan on using during the duration of the study any renin-angiotensin system (RAS)-acting drugs (including angiotensin-receptor blockers, or ARBs...
- people who have used chemotherapy agents, or who have a personal history of cancer or cancer in first degree relatives suggestive of elevated cancer risk, other than nonmetastatic skin cancer that has been completely...
- people with a history of bacterial, fungal, or viral infection requiring treatment with antibiotics, antifungal agents, or antivirals within 1 month prior to randomization.
- people who have used (within 14 days of randomization) or plan on using during the duration of the study any prescription or over-the-counter drugs that are moderate-strong CYP3A4 inducers or inhibitors.
- people who have used (within 14 days of randomization) or plan on using during the duration of the study any dietary aids, supplements, or foods that are moderate-strong CYP3A4 inhibitors (e.g., grapefruit juice).
- people with difficulty in swallowing oral medications.
- people with serious psychosocial comorbidities as determined by the Investigator.
- people with current cognitive or major psychiatric disorders, or any other condition that could interfere with compliance with study procedures.
- people with a positive drug or alcohol test (\>80 mg/dL) during Screening and/or admission (a positive THC test will be allowed as long as it consists of minimal social use, per discretion of Investigator), or with a...
- people who have used any other investigational drug within 1 month prior to enrollment. If the investigational drug is known to have a long half-life, a longer washout period will be done.
- people with a presence or history of active gastrointestinal disorder, including esophageal or gastroduodenal ulceration, or renal, hepatic, or coagulant disorder within 1 month prior to enrollment.
- people with a family history of significant cardiac disease (i.e., sudden death in first degree relative; myocardial infarction before the age of 50).
- people with confirmed COVID-19, or suspected COVID-19 (e.g., developed symptoms of a respiratory infection such as cough, sore throat, shortness of breath, or fever, but did not get tested for COVID 19) within 30 days...
- people who have received a COVID-19 vaccine within 30 days of randomization or are planning on receiving it during the study duration.
- Exclude people with spinal cord injury at T6 or higher with a history of neurogenic bladder.
- Exclude people with documented autonomic dysreflexia (AD) or a history of episodes consistent with undiagnosed AD as determined by an experienced clinician.
The study team makes the final eligibility decision.
Where it's taking place
- Augusta, Georgia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Augusta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.